After playing behind for much of the Covid-19 vaccine race, Novavax has come along with the first efficacy for its protein-based shot, including one of the first glimpses at how the first generation of vaccines perform against emerging variants.

Novavax announced its vaccine was 89.3% effective at stopping symptomatic Covid-19 in its Phase III study in the UK, as of the first interim analysis. The readout was based on 62 confirmed cases of symptomatic Covid-19, 56 of which came in the placebo group. Only one of the 62 cases was deemed severe, and also occurred in the placebo group.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,700+ biopharma pros reading Endpoints daily — and it's free.

SUBSCRIBE SIGN IN

Amgen is making a long-awaited move on the M&A side, buying South San Francisco-based Five Prime $FPRX for close to $2 billion and adding a slate of new cancer drugs to the pipeline.

Amgen is paying $38 a share, putting the deal value at $1.9 billion. The stock closed at $21.26 last night, giving investors a 78% premium.

The jewel in the crown of this deal is bemarituzumab, which Amgen describes as a first-in-class, Phase III-ready anti-FGFR2b antibody. Amgen was drawn to the bargaining table by Five Prime’s mid-stage data on gastric cancer, satisfied by PFS and OS data helping to validate FGFR2b as a target. Amgen researchers will now expand on the R&D program in other epithelial cancers, including lung, breast, ovarian and other cancers.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,700+ biopharma pros reading Endpoints daily — and it's free.

SUBSCRIBE SIGN IN

GlaxoSmithKline and Vir Biotechnology were hopeful that one of their partnered antibodies would carve out a win after getting the invite to a major NIH study in hospitalized Covid-19 patients. But just like Eli Lilly, the pair’s drug couldn’t hit the mark, and now they’ll be left to take a hard look at the game plan.

The NIH has shut down enrollment for GSK and Vir’s antibody VIR-7831 in its late-stage ACTIV-3 trial after the drug showed negligible effect in achieving sustained recovery in hospitalized Covid-19 patients, the partners said Wednesday.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,700+ biopharma pros reading Endpoints daily — and it's free.

SUBSCRIBE SIGN IN

You’d be forgiven for thinking that the only R&D effort of any consequence at Biogen belongs to aducanumab, its controversial Alzheimer’s drug. But behind the uproar around that drug, the big biotech has a full scale pipeline in play that includes a growing focus on developing gene therapies.

Now Biogen plans to build up the kind of manufacturing muscle that will give it an advantage in gaining FDA approvals — where CMC is always key — and then marketing them around the world.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,700+ biopharma pros reading Endpoints daily — and it's free.

SUBSCRIBE SIGN IN

Eli Lilly isn’t just gunning for a better diabetes drug in tirzepatide. They want to cut ahead of Novo Nordisk’s blockbuster rival Ozempic (semaglutide) on the obesity front as well. But a newly-claimed win in a head-to-head Phase III showdown over reducing A1C while shedding pounds — complete with clear evidence of superiority over the approved rival — could prove a tough sell right now.

Let’s start with the latest data from Lilly.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,700+ biopharma pros reading Endpoints daily — and it's free.

SUBSCRIBE SIGN IN